Shoulder Pain Clinical Trial
Official title:
Effect of Ultrasound-guided Hyaluronic or Corticosteroid Injections in Patients With Chronic Subacromial Bursitis
Verified date | January 2017 |
Source | Shin Kong Wu Ho-Su Memorial Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A randomized controlled trial to compare the effect of ultrasound-guided hyaluronic or corticosteroid injections in patients with chronic subacromial bursitis.
Status | Completed |
Enrollment | 207 |
Est. completion date | December 2016 |
Est. primary completion date | October 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility | Inclusion Criteria: 1. shoulder pain for more than 1 month 2. age = 20 years old 3. painful abduction or internal rotation with a visual analog scale (VAS) pain score =4 4. the presence of a painful arc of motion or pain at the middle to terminal range of shoulder abduction or internal rotation with a soft end feel 5. tenderness over the subacromial bursa 6. a reduction in pain of =40% on active shoulder abduction or internal rotation at the terminal range after injection of 3ml of 1%lidocain into the SASD bursa under ultrasound (US) guidance. Exclusion Criteria: 1. a history of uncontrolled chronic diseases, e.g., malignant neoplasms, blood dyscrasia, and infection 2. previous surgery of the affected shoulder 3. any evidence of a rotator cuff tear or tendinopathy, demonstrated by positive resistive tests or sonographic findings 4. calcification of the rotator cuff, demonstrated by x-ray or sonographic findings 5. the presence of arthritis, such as inflammatory arthritis (e.g., rheumatoid arthritis, seronegative spondyloarthropathy, or crystal-related arthropathy), osteoarthritis, frozen shoulder, subacromial spurs, or deformity of the acromion 6. the presence of instability of the affected shoulder 7. a previous fracture near the shoulder region 8. the presence of cervical radiculopathy or myelopathy 9. having received a corticosteroid or hyaluronic acid subacromial or shoulder joint injection in the past 3 months |
Country | Name | City | State |
---|---|---|---|
Taiwan | Shin Kong Wu Ho-Su Memorial Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
Shin Kong Wu Ho-Su Memorial Hospital | Ministry of Science and Technology, Taiwan |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline VAS pain score | The VAS scores for pain were obtained using a 100-mm-long horizontal line, with 0 mm on the left indicating no pain and 100 mm on the right indicating very severe pain. | baseline and 2 weeks | |
Secondary | the active ROM | The maximal active ROMs of the affected shoulder will be measured using a goniometer under the guidelines of the American Academy of Orthopedic Surgeons. These measurements included abduction in the frontal plane, forward flexion, internal rotation, and external rotation with the arm at 0 degrees of abduction. | between these time points: baseline, 2 weeks, 4 weeks (end of the intervention), 8 weeks, and 16 weeks | |
Secondary | Change of scores of the Shoulder Pain and Disability Index (SPADI) | The total SPADI score, which ranges between 0 and 100, is calculated by averaging the scores from the pain and disabilities subclasses. | between these time points: baseline, 2 weeks, 4 weeks (end of the intervention), 8 weeks, and 16 weeks | |
Secondary | Change of the Shoulder Disability Questionnaire (SDQ) | The SDQ is a symptoms-related questionnaire containing 16 items describing common situations that may induce symptoms in patients with shoulder disorders. By responding 'yes', 'no', or 'not applicable', the final score is obtained by dividing the number of positively scored items by the total number of applicable items and then multiplying this number by 100, which results in a final score ranging between 0 (no disability) and 100 (the worst situation). | between these time points: baseline, 2 weeks, 4 weeks (end of the intervention), 8 weeks, and 16 weeks | |
Secondary | Change of 36-item Short-Form Health Survey (SF-36) | The SF-36 is a 36-item questionnaire that evaluates the quality of life. It is composed of 8 subscales: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each subscale has a score range of 0 to 100, with a higher score indicating better health status.Patient's evaluation of the treatment effect. Patient's evaluation of the treatment effect consists of the answer to one question: "Is the treatment effective?" scored on a Likert scale (very effective=1, effective=2, not effective=3, worse=4, much worse=5). | between these time points: baseline, 2 weeks, 4 weeks (end of the intervention), 8 weeks, and 16 weeks |
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